Journal article
Safety and Immunogenicity of Full-Dose Trivalent Inactivated Influenza Vaccine (TIV) Compared With Half-Dose TIV Administered to Children 6 Through 35 Months of Age
Journal of the Pediatric Infectious Diseases Society, Vol.4(3), pp.214-224
09/2015
DOI: 10.1093/jpids/piu061
PMCID: PMC4554205
PMID: 26334249
Abstract
Children 6 through 35 months of age are recommended to receive half the dose of influenza vaccine compared with older children and adults.
This was a 6-site, randomized 2:1, double-blind study comparing full-dose (0.5 mL) trivalent inactivated influenza vaccine (TIV) with half-dose (0.25 mL) TIV in children 6 through 35 months of age. Children previously immunized with influenza vaccine (primed cohort) received 1 dose, and those with no previous influenza immunizations (naive cohort) received 2 doses of TIV. Local and systemic adverse events were recorded. Sera were collected before immunization and 1 month after last dose of TIV. Hemagglutination inhibition antibody testing was performed.
Of the 243 subjects enrolled (32 primed, 211 naive), data for 232 were available for complete analysis. No significant differences in local or systemic reactions were observed. Few significant differences in immunogenicity to the 3 vaccine antigens were noted. The immune response to H1N1 was significantly higher in the full-dose group among primed subjects. In the naive cohort, the geometric mean titer for all 3 antigens after 2 doses of TIV were significantly higher in the 12 through 35 months compared with the 6 through 11 months age group.
Our study confirms the safety of full-dose TIV given to children 6 through 35 months of age. An increase in antibody responses after full- versus half-dose TIV was not observed, except for H1N1 in the primed group. Larger studies are needed to clarify the potential for improved immunogenicity with higher vaccine doses. Recommending the same dose could simplify the production, storage, and administration of influenza vaccines.
Details
- Title: Subtitle
- Safety and Immunogenicity of Full-Dose Trivalent Inactivated Influenza Vaccine (TIV) Compared With Half-Dose TIV Administered to Children 6 Through 35 Months of Age
- Creators
- Natasha B Halasa - Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University, Nashville, TennesseeMichael A Gerber - Cincinnati Children's Hospital Medical Center, University of Cincinnati, OhioAndrea A Berry - Center for Vaccine Development, University of Maryland, BaltimoreEdwin L Anderson - Department of Medicine, St Louis University, MissouriPatricia Winokur - Department of Medicine, University of Iowa, Iowa CityHarry Keyserling - Department of Pediatrics, Emory University, Atlanta, GeorgiaAllison Ross Eckard - Department of Pediatrics, Emory University, Atlanta, GeorgiaHeather Hill - EMMES Corporation, Rockville, MarylandMark C Wolff - EMMES Corporation, Rockville, MarylandMonica M McNeal - Cincinnati Children's Hospital Medical Center, University of Cincinnati, OhioKathryn M Edwards - Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University, Nashville, TennesseeDavid I Bernstein - Cincinnati Children's Hospital Medical Center, University of Cincinnati, Ohio
- Resource Type
- Journal article
- Publication Details
- Journal of the Pediatric Infectious Diseases Society, Vol.4(3), pp.214-224
- DOI
- 10.1093/jpids/piu061
- PMID
- 26334249
- PMCID
- PMC4554205
- ISSN
- 2048-7193
- eISSN
- 2048-7207
- Grant note
- HHSN27220080000-6C / PHS HHS HHSN27220080000-13C / PHS HHS HHSN27220080000-5C / PHS HHS HHSN27220080000-7C / PHS HHS HHSN27220080000-3C / PHS HHS UL1TR000445 / NCATS NIH HHS 2 UL1 TR000442-06 / NCATS NIH HHS UL1 TR000445 / NCATS NIH HHS HHSN27220080000-8C / PHS HHS UL1 TR000442 / NCATS NIH HHS HHSN27220080000-57C / PHS HHS
- Language
- English
- Date published
- 09/2015
- Academic Unit
- Infectious Diseases; Medicine Administration; Internal Medicine
- Record Identifier
- 9984094345002771
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